Active Noninfectious Uveitis Affecting the Posterior SegmentPhase 1/2TITANNCT07218770
A Study of REGN7041 for Active Noninfectious Uveitis in Adult Participants
A Phase 1/2 study testing REGN7041 in people with Active Noninfectious Uveitis Affecting the Posterior Segment, run by Regeneron Pharmaceuticals at 5 sites in United States.
Trial summary
This study is researching an experimental drug called REGN7041 (also referred to as "study drug"). The study is focused on patients who have active inflammation inside of the eye without any signs of infection. The aim of the study is to see how safe and tolerable the study drug is. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Active Noninfectious Uveitis Affecting the Posterior Segment
- What is being tested?
- REGN7041
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 5 sitesUnited States
- Study dates
- 17 Dec 2025to 21 Jul 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of non-infectious anterior, intermediate, posterior or panuveitis (For anterior uveitis, there must be evidence of inflammation affecting the posterior segment), as defined in the protocol
- Active disease at baseline, as defined in the protocol
- Part A only: Best Corrected Visual Acuity (BCVA) of ≤65 and >10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent of worse than or equal to 20/50 and better than 20/630) at the screening visit and on day 1
- Part B only: BCVA of <75 and >10 ETDRS letters (Snellen equivalent of worse than 20/32 and better than 20/630) at the screening visit and on day 1
Who cannot join
- BCVA of ≤30 ETDRS letters (Snellen equivalent of 20/250 or worse) at the screening visit and/or on day 1
- Intraocular Pressure (IOP) <5 mm Hg at the screening visit and/or on day 1
- IOP >25 mm Hg on day 1. Participants are permitted to take IOP-lowering eye drops
- Confirmed or suspected infectious uveitis, as defined in the protocol
- NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Retina Consultants of Texas - Houston
Bellaire, Texas, 77401
Retina Consultants of Texas
Katy, Texas, 77494
Tennessee Retina
Nashville, Tennessee, 37203
Illinois Retina Associates
Oak Park, Illinois, 60304
Retinal Consultants - Sacramento
Sacramento, California, 95825
About this study
Official title: A Phase 1/2a Study of REGN7041 (Anti-CD3 Monoclonal Antibody) in Participants With Active Noninfectious Uveitis Affecting the Posterior Segment
This study is researching an experimental drug called REGN7041 (also referred to as "study drug"). The study is focused on patients who have active inflammation inside of the eye without any signs of infection.
The aim of the study is to see how safe and tolerable the study drug is. This is the first time the study drug is being tested in humans.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood and the fluid in the eye at different times
- Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
- Being tested
- REGN7041
- Keywords
- NIU-PS, Intermediate, Posterior, Panuveitis, Anterior, Uveitis, Angiographic Cystoid Macular Edema (CME), Retinal vascular leakage
- Medical subject headings
- Panuveitis, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN7041Drug
Administered as per the protocol
| Study group | Role | What they receive |
|---|---|---|
| Sequential Single Ascending Dose Cohorts | Experimental | Not described Receives: Drug: REGN7041 |
| Sequential Multiple Ascending Dose Cohorts | Experimental | Not described Receives: Drug: REGN7041 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Through Week 24
Secondary outcomes (3)
Concentrations of REGN7041 in serum
Measured: Through Week 24
Incidence of Anti-Drug Antibodies (ADAs) to REGN7041 in serum
Measured: Through Week 24
Magnitude of ADAs to REGN7041 in serum
Measured: Through Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start17 Dec 2025
- Primary completion21 Jul 2026
- Study completion21 Jul 2026
Why it stopped: Unfavorable benefit-risk assessment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Noninfectious Uveitis Affecting the Posterior SegmentStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218770
- Sponsor's protocol ID
- R7041-NIU-24123
- Other IDs
- 2025-521713-57-00, 2025
- Acronym
- TITAN
- Status last verified
- Aug 2026
- First submitted
- 16 Oct 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Study of REGN7041 (Anti-CD3 Monoclonal Antibody) in Participants With Active Noninfectious Uveitis Affecting the Posterior Segment
- ClinicalTrials.gov ID
- NCT07218770
- Acronym / sponsor ID
- TITAN / R7041-NIU-24123
- Keywords
- NIU-PS, Intermediate, Posterior, Panuveitis, Anterior, Uveitis, Angiographic Cystoid Macular Edema (CME), Retinal vascular leakage
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unfavorable benefit-risk assessment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 21 Jul 2026 (actual)
- Study completion
- 21 Jul 2026 (actual)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is researching an experimental drug called REGN7041 (also referred to as "study drug"). The study is focused on patients who have active inflammation inside of the eye without any signs of infection.
The aim of the study is to see how safe and tolerable the study drug is. This is the first time the study drug is being tested in humans.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood and the fluid in the eye at different times
- Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequential Single Ascending Dose Cohorts | Experimental | Drug: REGN7041 |
| Sequential Multiple Ascending Dose Cohorts | Experimental | Drug: REGN7041 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of non-infectious anterior, intermediate, posterior or panuveitis (For anterior uveitis, there must be evidence of inflammation affecting the posterior segment), as defined in the protocol
- Active disease at baseline, as defined in the protocol
- Part A only: Best Corrected Visual Acuity (BCVA) of ≤65 and >10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent of worse than or equal to 20/50 and better than 20/630) at the screening visit and on day 1
- Part B only: BCVA of <75 and >10 ETDRS letters (Snellen equivalent of worse than 20/32 and better than 20/630) at the screening visit and on day 1
Key exclusion criteria (5 listed)
- BCVA of ≤30 ETDRS letters (Snellen equivalent of 20/250 or worse) at the screening visit and/or on day 1
- Intraocular Pressure (IOP) <5 mm Hg at the screening visit and/or on day 1
- IOP >25 mm Hg on day 1. Participants are permitted to take IOP-lowering eye drops
- Confirmed or suspected infectious uveitis, as defined in the protocol
- NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGN7041Administered as per the protocol | Drug | Sequential Multiple Ascending Dose Cohorts, Sequential Single Ascending Dose Cohorts |
Primary outcome
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Through Week 24
3 secondary outcomes
Concentrations of REGN7041 in serum
Time frame: Through Week 24
Incidence of Anti-Drug Antibodies (ADAs) to REGN7041 in serum
Time frame: Through Week 24
Magnitude of ADAs to REGN7041 in serum
Time frame: Through Week 24
Results and safety
The study was stopped early (reason given: Unfavorable benefit-risk assessment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing REGN7041 in people with Active Noninfectious Uveitis Affecting the Posterior Segment, run by Regeneron Pharmaceuticals at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unfavorable benefit-risk assessment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Treatment-Emergent Adverse Events (TEAEs) (time frame: Through Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.